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VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma


OBJECTIVES:

- Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly
diagnosed stage II or III multiple myeloma.

- Determine the incidence and severity of peripheral motor/sensory neuropathy in patients
treated with this regimen.

- Assess the ability to mobilize and collect stem cells in patients who undergo future
autologous peripheral stem cell transplantation.

- Determine the time to response in patients treated with this regimen.

- Assess the quality of life of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on
days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to
undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to
transplantation off study. Patients who do not undergo transplantation receive 2 additional
courses of therapy beyond best response for up to 8 courses in the absence of disease
progression or unacceptable toxicity.

Patients who achieve at least a partial response after completion of treatment may receive
maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide* once daily
OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in
the absence of disease progression or unacceptable toxicity.

NOTE: *For patients who had previously discontinued thalidomide, maintenance therapy may
consist of bortezomib only.

Quality of life is assessed at baseline, at the beginning of each study course, and after
completion of study treatment.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed Salmon-Durie stage II or III multiple myeloma

- Untreated disease OR patient underwent prior therapy for this cancer that lasted
no more than 2 weeks

- Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)

- No evidence of cord compression requiring concurrent steroids

PATIENT CHARACTERISTICS:

- Creatinine clearance ≥ 30 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 methods of contraception, including ≥ 1 highly effective
method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment

- No known HIV positivity

- No peripheral neuropathy ≥ grade 2

- No hypersensitivity to bortezomib, boron, or mannitol

PRIOR CONCURRENT THERAPY:

- No prior bortezomib

- More than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks

- No steroids within 14 days prior to study entry

- No concurrent corticosteroids except for the treatment of a nonmalignant condition

- May not exceed the equivalent dose of prednisone 10 mg/day

- No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor efficacy

Safety Issue:

No

Principal Investigator

Ivan Borrello, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000450772

NCT ID:

NCT00287872

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410